aprevo® anterior lumbar interbody fusion device - aprevo® Cervical ACDF-X

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250827

Identifiers

510(k) Number: K250827 FDA 510(k)
FDA Product Code: MAX FDA 510(k)
Models / Variants: aprevo® anterior lumbar interbody fusion device FDA 510(k)
aprevo® lateral lumbar interbody fusion device FDA 510(k)
aprevo® anterior lumbar interbody fusion device with interfixation FDA 510(k)
aprevo® transforaminal lumbar interbody fusion device FDA 510(k)
aprevo® TLIF-CA Articulating System FDA 510(k)
aprevo® Cervical ACDF FDA 510(k)
aprevo® Cervical ACDF-X FDA 510(k)
aprevo® Cervical ACDF-X No Cams FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 888.3080 FDA 510(k)
Regulation Number: 888.3080 FDA 510(k)
Advisory Committee: Orthopedic FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Aprevo devices are designed to stabilize the lumbar spinal column and facilitate fusion. They are intended for interbody fusion in skeletally mature patients and are to be used with supplemental fixation instrumentation. The devices incorporate patient-specific features and include an aperture for the packing of bone graft.

The Aprevo devices are supplied in various configurations, including the ALIF interbody system, LLIF interbody system, and ALIF-X interbody system. They are used in the lumbar spine and are designed to be used with supplemental fixation instrumentation. The devices have been cleared by the FDA, with a clearance type of Traditional and a decision code of SESE.

Frequently asked questions

What is the Aprevo device used for?

The Aprevo device is used for interbody fusion in the lumbar spine to stabilize the spinal column and facilitate fusion in skeletally mature patients.

How is the Aprevo device supplied?

The Aprevo device is supplied in various configurations, including the ALIF interbody system, LLIF interbody system, and ALIF-X interbody system.

Is the Aprevo device used with other instrumentation?

Yes, the Aprevo device is designed to be used with supplemental fixation instrumentation to stabilize the lumbar spinal column.

What is the regulatory status of the Aprevo device?

The Aprevo device has been cleared by the FDA with a clearance type of Traditional and a decision code of SESE.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF aprevo® anterior and lateral lumbar interbody system, aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar ..., PDF aprevo® anterior and lateral lumbar interbody system

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K250827	Class II	Active

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Manufacturer

Manufacturer: Carlsmed, Inc.

Sources (1)

FDA 510(k) K250827 24 fields · synced Oct 6, 2026